Systems and methods for blood glucose sensing

ABSTRACT

A system for measuring a glucose level in a blood sample includes a test strip and a meter. The test strip includes a sample chamber, a working electrode, a counter electrode, fill-detect electrodes, and an auto-on conductor. A reagent layer is disposed in the sample chamber. The auto-on conductor causes the meter to wake up and perform a test strip sequence when the test strip is inserted in the meter. The meter uses the working and counter electrodes to initially detect the blood sample in the sample chamber and uses the fill-detect electrodes to check that the blood sample has mixed with the reagent layer. The meter applies an assay voltage between the working and counter electrodes and measures the resulting current. The meter calculates the glucose level based on the measured current and calibration data saved in memory from a removable data storage device associated with the test strip.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a divisional of U.S. patent application Ser.No. 10/286,648, filed Nov. 1, 2002, which claims priority on U.S.Provisional Patent Application Serial No. 60/375,017, filed Apr. 25,2002, U.S. Provisional Patent Application Serial No. 60/375,019, filedApr. 25, 2002, U.S. Provisional Patent Application Serial No.60/375,020, filed Apr. 25, 2002, and U.S. Provisional Patent ApplicationSerial No. 60/375,054, filed Apr. 25, 2002, all of which are fullyincorporated herein by reference.

BACKGROUND

[0002] 1. Field of the Invention

[0003] The present invention relates to electrochemical sensors and,more particularly, to systems and methods for sensing blood glucoselevels electrochemically.

[0004] 2. Description of Related Art

[0005] Many people, such as diabetics, have a need to monitor theirblood glucose levels on a daily basis. A number of systems that allowpeople to conveniently monitor their blood glucose levels are available.Such systems typically include a test strip where the user applies ablood sample and a meter that “reads” the test strip to determine theglucose level in the blood sample.

[0006] Among the various technologies available for measuring bloodglucose levels, electrochemical technologies are particularly desirablebecause only a very small blood sample may be needed to perform themeasurement. In electrochemical-based systems, the test strip typicallyincludes a sample chamber that contains reagents, such as glucoseoxidase and a mediator, and electrodes. When the user applies a bloodsample to the sample chamber, the reagents react with the glucose, andthe meter applies a voltage to the electrodes to cause a redox reaction.The meter measures the resulting current and calculates the glucoselevel based on the current.

[0007] It should be emphasized that accurate measurements of bloodglucose levels may be critical to the long-term health of many users. Asa result, there is a need for a high level of reliability in the metersand test strips used to measure blood glucose levels. However, as samplesizes become smaller, the dimensions of the sample chamber andelectrodes in the test strip also become smaller. This, in turn, maymake test strips become more sensitive to smaller manufacturing defectsand to damage from subsequent handling.

[0008] Accordingly, there is a need to provide blood glucose measuringsystems and methods with features for measuring blood glucose levelsconveniently and reliably.

SUMMARY

[0009] In a first principal aspect, the present invention provides atest strip for testing a blood sample. The test strip comprises a samplechamber for the blood sample, at least four electrodes for measuring atleast one electrical characteristic of the blood sample in the samplechamber, a plurality of electrical contacts electrically connected tothe at least four electrodes, and at least one auto-on electricalcontact electrically isolated from the at least four electrodes. The atleast four electrodes include a working electrode, a counter electrode,a fill-detect anode, and a fill-detect cathode.

[0010] In a second principal aspect, the present invention provides amethod of making a plurality of test strips. In accordance with themethod, a plurality of test strip structures are formed on one sheet,and the test strip structures are separated into test strips. Each ofthe test strip structures includes a sample chamber, a plurality ofelectrodes (including a working electrode, a counter electrode, afill-detect anode, and a fill-detect cathode), a plurality of electricalcontacts electrically connected to the electrodes, and at least oneauto-on electrical contact electrically isolated from the plurality ofelectrodes.

[0011] In a third principal aspect, the present invention provides amethod of using a test strip to test a blood sample. The test stripincludes a sample chamber, a working electrode, a counter electrode, apair of fill-detect electrodes, and an auto-on conductor. In accordancewith the method, the test strip is inserted into a meter that is in asleep mode. The meter detects an auto-on current through the auto-onconductor and responsively enters an active mode. The blood sample isapplied to the sample chamber. The meter detects the blood sample in thesample chamber by applying a fill-detect voltage between the fill-detectelectrodes and measuring a fill-detect current flowing between thefill-detect electrodes. The meter applies an assay voltage between theworking and counter electrodes and makes at least one measurement of theresulting current. The meter determines a test result from the at leastone current measurement.

[0012] In a fourth principal aspect, the present invention provides amethod of strip identification. A strip that includes an auto-onconductor is inserted into a meter that is in a sleep mode. The meterdetects the strip by detecting a current flow through the auto-onconductor, and responsively enters an active mode. The meter measures avoltage drop across the auto-on conductor and identifies the strip aseither a test strip or a check strip based on the voltage drop. If thestrip is a test strip, the meter performs a test strip sequence. If thestrip is a check strip, the meter performs a check strip sequence.

[0013] In a fifth principal aspect, the present invention provides aremovable data storage device for a meter that uses test strips tomeasures glucose levels in blood samples. The removable data storagedevice comprises a carrier, a circuit board mounted to the carrier, anda memory mounted to the circuit board. The carrier has a proximal endand a distal end and is keyed for inserting the distal end into themeter in a preferred orientation. The circuit board includes a pluralityof electrical contacts for electrically connecting to the meter. Theplurality of electrical contacts includes a ground contact and a voltagesupply contact. The ground contact extends closer to the distal end thanthe voltage supply contact. The memory stores data for use by the meter,including calibration coefficients for a plurality of test strips. Thememory is electrically connected to the plurality of electrical contactson the circuit board. When the removable data storage device is insertedinto the meter in the preferred orientation, the ground contact becomeselectrically connected to the meter before the voltage supply contact.

[0014] In a sixth principal aspect, the present invention provides ameter for use in combination with a test strip. The test strip includesa working electrode, a counter electrode, a pair of fill-detectelectrodes, and an auto-on conductor. The meter comprises a stripconnector for receiving the test strip, a processor, a memory, aplurality of machine instructions stored in the memory and executable bythe processor for performing a test strip sequence, and a dataacquisition system controlled by the processor. When the test strip isinserted in the strip connector, the data acquisition system applies atleast a first voltage between the working and counter electrodes andmeasures any resulting current flowing between the working and counterelectrodes, applies at least a second voltage between the fill-detectelectrodes and measures any resulting current flowing between thefill-detect electrodes, and measures a voltage drop across the auto-onconductor. The data acquisition system includes at least onedigital-to-analog converter and at least one analog-to-digitalconverter.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015]FIG. 1 is a top plan view of a test strip, in accordance with apreferred embodiment of the present invention.

[0016]FIG. 2 is a top plan view of the test strip of FIG. 1, with thecover, adhesive layer, and reagent layer cut away, in accordance with apreferred embodiment of the present invention.

[0017]FIG. 3 is a cross-sectional view of the test strip of FIG. 1,taken along line 3-3, in accordance with a preferred embodiment of thepresent invention.

[0018]FIG. 4 is a top schematic view of an array of test stripstructures, which may be separated into a plurality of test strips ofthe type shown in FIGS. 1-3, in accordance with a preferred embodimentof the present invention.

[0019]FIG. 5 is top plan view of an intermediate stage in the formationof one of the test strip structures of FIG. 4, in accordance with apreferred embodiment of the present invention.

[0020]FIG. 6 is top plan view of an intermediate stage in the formationof one of the test strip structures of FIG. 4, in accordance with apreferred embodiment of the present invention.

[0021]FIG. 7 is top plan view of an intermediate stage in the formationof one of the test strip structures of FIG. 4, in accordance with apreferred embodiment of the present invention.

[0022]FIG. 8 is top plan view of an intermediate stage in the formationof one of the test strip structures of FIG. 4, in accordance with apreferred embodiment of the present invention.

[0023]FIG. 9 is top plan view of one of the test strip structures ofFIG. 4, in accordance with a preferred embodiment of the presentinvention.

[0024]FIG. 10 is a perspective view of a meter, in accordance with apreferred embodiment of the present invention.

[0025]FIG. 11 is a perspective view of the meter of FIG. 10, with aremovable data storage device inserted in it, in accordance with apreferred embodiment of the present invention.

[0026]FIG. 12 is a perspective view of a strip connector in the meter ofFIG. 10, in accordance with a preferred embodiment of the presentinvention.

[0027]FIG. 13 is an exploded perspective view of the removable datastorage device of FIG. 11, in accordance with a preferred embodiment ofthe present invention.

[0028]FIG. 14 is a flow chart illustrating a method of using a teststrip or a check strip, in accordance with a preferred embodiment of thepresent invention.

[0029]FIG. 15 is a flow chart illustrating a method of using a checkstrip, in accordance with a preferred embodiment of the presentinvention.

[0030]FIG. 16 is a flow chart illustrating a method of using a teststrip, in accordance with a preferred embodiment of the presentinvention.

[0031]FIG. 17 is a flow chart illustrating a method of using a teststrip, in accordance with a preferred embodiment of the presentinvention.

[0032]FIG. 18 is a simplified schematic diagram of the electronics ofthe meter of FIG. 10, in accordance with a preferred embodiment of thepresent invention.

[0033]FIG. 19 is a simplified schematic diagram of the electricalconnections between the meter of FIG. 10 and the electrodes of the teststrip of FIG. 1, in accordance with a preferred embodiment of thepresent invention.

[0034]FIG. 20 is a simplified schematic diagram of the electricalconnections between the meter of FIG. 10 and the auto-on conductor ofthe test strip of FIG. 1, in accordance with a preferred embodiment ofthe present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] In accordance with a preferred embodiment, a system for measuringa glucose level in a blood sample includes a test strip and a meter. Thesystem may also include a removable data storage device associated witha lot of test strips. The removable data storage device stores data foruse by the meter, such as calibration coefficients for test strips fromthat lot. The system may also include a check strip that the user mayinsert into the meter to check that the meter is functioning properly.

[0036] The test strip includes a sample chamber for receiving the bloodsample. The sample chamber has a first opening in the proximal end ofthe test strip and a second opening for venting the sample chamber. Thesample chamber may be dimensioned so as to be able to draw the bloodsample in through the first opening, and to hold the blood sample in thesample chamber, by capillary action. The test strip may include atapered section that is narrowest at the proximal end, in order to makeit easier for the user to locate the first opening and apply the bloodsample.

[0037] A working electrode, a counter electrode, a fill-detectelectrode, and a fill-detect anode are disposed in the sample chamber. Areagent layer is disposed in the sample chamber and preferably covers atleast the working electrode. The reagent layer may include an enzyme,such as glucose oxidase, and a mediator, such as potassium ferricyanide.The test strip has, near its distal end, a plurality of electricalcontacts that are electrically connected to the electrodes viaconductive traces. The test strip also has near its distal end anauto-on conductor, which may be electrically isolated from theelectrodes.

[0038] The meter may be battery powered and may stay in a low-powersleep mode when not in use in order to save power. When the test stripis inserted into the meter, the electrical contacts on the test stripcontact corresponding electrical contacts in the meter. In addition, theauto-on conductor bridges a pair of electrical contacts in the meter,causing a current to flow through the auto-on conductor. The currentflow through the auto-on conductor causes the meter to wake up and enteran active mode. The meter also measures the voltage drop across theauto-on conductor and identifies the inserted strip as either a teststrip or a check strip based on the voltage drop. If the meter detects acheck strip, it performs a check strip sequence. If the meter detects atest strip, it performs a test strip sequence.

[0039] In the test strip sequence, the meter validates the workingelectrode, counter electrode, and fill-detect electrodes by confirmingthat there are no low-impedance paths between any of these electrodes.If the electrodes are valid, the meter indicates to the user that samplemay be applied to the test strip. The meter then applies a drop-detectvoltage between the working and counter electrodes and detects the bloodsample by detecting a current flow between the working and counterelectrodes (i.e., a current flow through the blood sample as it bridgesthe working and counter electrodes). To detect that adequate sample ispresent in the sample chamber and that the blood sample has traversedthe reagent layer and mixed with the chemical constituents in thereagent layer, the meter applies a fill-detect voltage between thefill-detect electrodes and measures any resulting current flowingbetween the fill-detect electrodes. If this resulting current reaches asufficient level within a predetermined period of time, the meterindicates to the user that adequate sample is present and has mixed withthe reagent layer.

[0040] The meter waits for an incubation period of time after initiallydetecting the blood sample, to allow the blood sample to react with thereagent layer. Then, during a measurement period, the meter applies anassay voltage between the working and counter electrodes and takes oneor more measurements of the resulting current flowing between theworking and counter electrodes. The assay voltage is near the redoxpotential of the chemistry in the reagent layer, and the resultingcurrent is related to the glucose level in the blood sample. The metercalculates the glucose level based on the measured current and oncalibration data that the meter previously downloaded from the removabledata storage device associated with the test strip and stored in themeter's memory. The meter then displays the calculated glucose level tothe user.

[0041] 1. Test Strip Configuration

[0042] With reference to the drawings, FIGS. 1, 2, and 3 show a teststrip 10, in accordance with a preferred embodiment of the presentinvention. Test strip 10 preferably takes the form of a generally flatstrip that extends from a proximal end 12 to a distal end 14.Preferably, test strip 10 is sized for easy handling. For example, teststrip 10 may be about 1⅜ inches along its length (i.e., from proximalend 12 to distal end 14) and about {fraction (5/16)} inches wide.However, proximal end 12 may be narrower than distal end 14. Thus, teststrip 10 may include a tapered section 16, in which the full width oftest strip 10 tapers down to proximal end 12, making proximal end 12narrower than distal end 14. As described in more detail below, the userapplies the blood sample to an opening in proximal end 12 of test strip10. Thus, providing tapered section 16 in test strip 10, and makingproximal end 12 narrower than distal end 14, may help the user to locatethe opening where the blood sample is to be applied and may make iteasier for the user to successfully apply the blood sample to test strip10.

[0043] As best shown in FIG. 3, test strip 10 may have a generallylayered construction. Working upward from the lowest layer, test strip10 may include a base layer 18 extending along the entire length of teststrip 10. Base layer 18 is preferably composed of an electricallyinsulating material and has a thickness sufficient to provide structuralsupport to test strip 10. For example, base layer 18 may be polyesterthat is about 0.014 inches think.

[0044] Disposed on base layer 18 is a conductive pattern 20. Conductivepattern 20 includes a plurality of electrodes disposed on base layer 18near proximal end 12, a plurality of electrical contacts disposed onbase layer 18 near distal end 14, and a plurality of conductive traceselectrically connecting the electrodes to the electrical contacts. In apreferred embodiment, the plurality of electrodes includes a workingelectrode 22, a counter electrode 24, which may include a first section25 and a second section 26, a fill-detect anode 28, and a fill-detectcathode 30. Correspondingly, the electrical contacts may include aworking electrode contact 32, a counter electrode contact 34, afill-detect anode contact 36, and a fill-detect cathode contact 38. Theconductive traces may include a working electrode trace 40, electricallyconnecting working electrode 22 to working electrode contact 32, acounter electrode trace 42, electrically connecting counter electrode 24to counter electrode contact 34, a fill-detect anode trace 44electrically connecting fill-detect anode 28 to fill-detect contact 36,and a fill-detect cathode trace 46 electrically connecting fill-detectcathode 30 to fill-detect cathode contact 38. In a preferred embodiment,conductive pattern 20 also includes an auto-on conductor 48 disposed onbase layer 18 near distal end 14.

[0045] A dielectric layer 50 may also be disposed on base layer 18, soas to cover portions of conductive pattern 20. Preferably, dielectriclayer 50 is a thin layer (e.g., about 0.0005 inches thick) and iscomposed of an electrically insulating material, such as silicones,acrylics, or mixtures thereof. Dielectric layer 50 may cover portions ofworking electrode 22, counter electrode 24, fill-detect anode 28,fill-detect cathode 30, and conductive traces 40-46, but preferably doesnot cover electrical contacts 32-38 or auto-on conductor 48. Forexample, dielectric layer 50 may cover substantially all of base layer18, and the portions of conductive pattern 20 thereon, from a line justproximal of contacts 32 and 34 all the way to proximal end 12, exceptfor a slot 52 extending from proximal end 12. In this way, slot 52 maydefine an exposed portion 54 of working electrode 22, exposed portions56 and 58 of sections 25 and 26 of counter electrode 24, an exposedportion 60 of fill-detect anode 28, and an exposed portion 62 offill-detect cathode 30. As shown in FIG. 2, slot 52 may have differentwidths in different sections, which may make exposed portions 60 and 62of fill-detect electrodes 28 and 30 wider than exposed portions 54, 56,and 58 of working electrode 22 and counter electrode sections 25 and 26.

[0046] The next layer in test strip 10 may be a dielectric spacer layer64 disposed on dielectric layer 50. Dielectric spacer layer 64 iscomposed of an electrically insulating material, such as polyester.Dielectric spacer layer 64 may have a length and width similar to thatof dielectric layer 50. In addition, spacer 64 may include a slot 66that is substantially aligned with slot 52. Thus, slot 66 may extendfrom a proximal end 68, aligned with proximal end 12, back to a distalend 70, such that exposed portions 54-62 of working electrode 22,counter electrode 24, fill-detect anode 28, and fill-detect cathode 30are located in slot 66.

[0047] A cover 72, having a proximal end 74 and a distal end 76, may beattached to dielectric spacer layer 64 via an adhesive layer 78. Cover72 is composed of an electrically insulating material, such aspolyester, and may have a thickness of about 0.004 inches. Preferably,cover 72 is transparent.

[0048] Adhesive layer 78 may include a polyacrylic or other adhesive andhave a thickness of about 0.0005 inches. Adhesive layer 78 may consistof a first section 80 and a second section 82 disposed on spacer 64 onopposite sides of slot 66. A break 84 in adhesive layer 78 betweensections 80 and 82 extends from distal end 70 of slot 66 to an opening86. Cover 72 may be disposed on adhesive layer 78 such that its proximalend 74 is aligned with proximal end 12 and its distal end 76 is alignedwith opening 86. In this way, cover 72 covers slot 66 and break 84.

[0049] Slot 66, together with base layer 18 and cover 72, defines asample chamber 88 in test strip 10 for receiving a blood sample formeasurement. Proximal end 68 of slot 66 defines a first opening insample chamber 88, through which the blood sample is introduced intosample chamber 88. At distal end 70 of slot 66, break 84 defines asecond opening in sample chamber 88, for venting sample chamber 88 assample enters sample chamber 88. Slot 66 is dimensioned such that ablood sample applied to its proximal end 68 is drawn into and held insample chamber 88 by capillary action, with break 84 venting samplechamber 88 through opening 86, as the blood sample enters. Moreover,slot 66 is dimensioned so that the blood sample that enters samplechamber 88 by capillary action is about 1 microliter or less. Forexample, slot 66 may have a length (i.e., from proximal end 68 to distalend 70) of about 0.140 inches, a width of about 0.060 inches, and aheight (which may be substantially defined by the thickness ofdielectric spacer layer 64) of about 0.005 inches. Other dimensionscould be used, however.

[0050] A reagent layer 90 is disposed in sample chamber 88. Preferably,reagent layer 90 covers at least exposed portion 54 of working electrode22. Most preferably, reagent layer 90 also at least touches exposedportions 56 and 58 of counter electrode 24. Reagent layer 90 includeschemical constituents to enable the level of glucose in the blood sampleto be determined electrochemically. Thus, reagent layer 90 may includean enzyme specific for glucose, such as glucose oxidase, and a mediator,such as potassium ferricyanide. Reagent layer 90 may also include othercomponents, such as buffering materials (e.g., potassium phosphate),polymeric binders (e.g., hydroxypropyl-methyl-cellulose, sodiumalginate, microcrystalline cellulose, polyethylene oxide,hydroxyethylcellulose, and/or polyvinyl alcohol), and surfactants (e.g.,Triton X-100 or Surfynol 485).

[0051] With these chemical constituents, reagent layer 90 reacts withglucose in the blood sample in the following way. The glucose oxidaseinitiates a reaction that oxidizes the glucose to gluconic acid andreduces the ferricyanide to ferrocyanide. When an appropriate voltage isapplied to working electrode 22, relative to counter electrode 24, theferrocyanide is oxidized to ferricyanide, thereby generating a currentthat is related to the glucose concentration in the blood sample.

[0052] As best shown in FIG. 3, the arrangement of the various layers intest strip 10 may result in test strip 10 having different thicknessesin different sections. In particular, among the layers above base layer18, much of the thickness of test strip 10 may come from the thicknessof spacer 64. Thus, the edge of spacer 64 that is closest to distal end14 may define a shoulder 92 in test strip 10. Shoulder 92 may define athin section 94 of test strip 10, extending between shoulder 92 anddistal end 14, and a thick section 96, extending between shoulder 92 andproximal end 12. The elements of test strip 10 used to electricallyconnect it to the meter, namely, electrical contacts 32-38 and auto-onconductor 48, may all be located in thin section 94. Accordingly, theconnector in the meter may be sized so as to be able to receive thinsection 94 but not thick section 96, as described in more detail below.This may beneficially cue the user to insert the correct end, i.e.,distal end 14 in thin section 94, and may prevent the user frominserting the wrong end, i.e., proximal end 12 in thick section 96, intothe meter.

[0053] Although FIGS. 1-3 illustrate a preferred configuration of teststrip 10, other configurations could be used. For example, in theconfiguration shown in FIGS. 1-3, counter electrode 24 is made up twosections, a first section 25 that is on the proximal side of workingelectrode 22 and a second section 26 that is on the distal side ofworking electrode 22. Moreover, the combined area of the exposedportions 56 and 58 of counter electrode 24 is preferably greater thanthe area of the exposed portion 54 of working electrode 22. In thisconfiguration, counter electrode 24 effectively surrounds workingelectrode 22, which beneficially shields working electrode 22electrically. In other configurations, however, counter electrode 24 mayhave only one section, such as first section 25.

[0054] Different arrangements of fill-detect electrodes 28 and 30 mayalso be used. In the configuration shown in FIGS. 1-3, fill-detectelectrodes 28 and 30 are in a side-by-side arrangement. Alternatively,fill-detect electrodes 28 and 30 may be in a sequential arrangement,whereby, as the sample flows through sample chamber 88 toward distal end70, the sample contacts one of the fill-detect electrodes first (eitherthe anode or the cathode) and then contacts the other fill-detectelectrode. In addition, although exposed portions 60 and 62 offill-detect electrodes 28 and 30 are wider than exposed portions 54, 56,and 58 of working electrode 22 and counter electrode sections 25 and 26in the embodiment shown in FIG. 2, they may have the same or a narrowerwidth in other embodiments.

[0055] However they are arranged relative to each other, it ispreferable for fill-detect electrodes 28 and 30 to be located on thedistal side of reagent layer 90. In this way, as the sample flowsthrough sample chamber 88 toward distal end 70, the sample will havetraversed reagent layer 90 by the time it reaches fill-detect electrodes28 and 30. This arrangement beneficially allows the fill-detectelectrodes 28 and 30 to detect not only whether sufficient blood sampleis present in sample chamber 88 but also to detect whether the bloodsample has become sufficiently mixed with the chemical constituents ofreagent layer 90. Thus, if reagent layer 90 covers working electrode 22,as is preferable, then it is preferable to locate fill-detect electrodes28 and 30 on the distal side of working electrode 22, as in theconfiguration shown in FIGS. 1-3. Other configurations may be used,however.

[0056] 2. Method of Manufacturing Test Strips

[0057] With reference to FIG. 4, a plurality of test strips 10 may bemass-produced by forming an integrated structure 100 that includes aplurality of test strip structures 102 all on one sheet. The test stripstructures 102 may be arranged in an array that includes a plurality ofrows 104 (e.g., six rows), with each row 104 including a plurality oftest strip structures 102 (e.g., fifty test strip structures in eachrow). The plurality of test strips 10 may then be formed by separatingthe test strip structures 102 from each other. In a preferred separationprocess, each row 104 of test strip structures 102 is first punched outof integrated structure 100. This punching process may provide some ofthe outer shape of the test strips 10. For example, the tapered shape oftapered sections 16 of the test strips 10 may be formed in this punchingprocess. Next, a slitting process may be used to separate the test stripstructures 102 in each row 104 into individual test strips 10.

[0058]FIGS. 5 through 9 show only one test strip structure (eitherpartially or completely fabricated), in order to illustrate varioussteps in a preferred method for forming the test strip structures 102.In this preferred approach, the test strip structures 102 in integratedstructure 100 are all formed on a sheet of material that serves as baselayer 18 in the finished test strips 10. The other components in thefinished test strips 10 are then built up layer-by-layer on top of baselayer 18 to form the test strip structures 102. In each of FIGS. 5through 9, the outer shape of the test strip 10 that would be formed inthe overall manufacturing process is shown as a dotted line.

[0059] As shown in FIG. 5, the manufacturing process may begin byforming, for each test strip structure, a first conductive pattern 110on base layer 18. First conductive pattern 110 may include electricalcontacts 32-38, conductive traces 40-42, and auto-on conductor 48. Firstconductive pattern 110 may be formed by screen-printing a firstconductive ink onto base layer 18. The first conductive ink may beprovided as a viscous liquid that includes particles of a conductivematerial, such as metallic silver. For example, a preferred firstconductive ink has a composition of about 30-60 weight % metallicsilver, about 5-10 weight % lamp black, about 30-60 weight % dipropyleneglycol monomethyl ether, and other components, and is available fromE.I. DuPont de Nemours & Co., Wilmington, Del., as “Membrane SwitchComposition 5524.”

[0060] As shown in FIG. 6, a second conductive pattern 112 may then beformed on base layer 18. Second conductive pattern 112 may includeworking electrode 22, first section 25 and second section 26 of counterelectrode 24, fill-detect anode 28, and fill-detect cathode 30. Secondconductive pattern 112 may be formed by screen-printing a secondconductive ink onto base layer 18. The second conductive ink may beprovided as a viscous liquid that includes particles of a conductivematerial, such as graphite. The second conductive ink may have adifferent composition than the first conductive ink. In particular, thesecond conductive ink is preferably substantially of free of materials,such as silver, that can interfere with the chemistry of reagent layer90. A preferred second conductive ink has a composition of about 10-20weight % graphite, about 5-10 weight % lamp black, greater than 60weight % ethylene glycol diacetate, and about 5-10 weight % polymer, andis available from E.I. DuPont de Nemours & Co., Wilmington, Del., as“E100735-111.”

[0061] As shown in FIG. 7, dielectric layer 50 may then be formed onbase layer 18 so as to cover portions of first conductive pattern 110and second conductive pattern 112. As shown in FIG. 7, dielectric layer50 may extend beyond the outline of a finished test strip 10 so as tocover multiple test strip structures being formed on base layer 18. Alsoas shown in FIG. 7, dielectric layer 50 may include a slot 114 thatdefines exposed portions 54, 56, 58, 60, and 62 of working electrode 22,first counter electrode section 25, second counter electrode section 26,fill-detect anode portion 28, and fill-detect cathode portion 30. Slot52 in test strip 10 corresponds to the part of slot 114 that remains intest strip 10 after the test strip structures are separated into teststrips. In this regard, slot 114 may include a wide section 115 to allowthe portions of fill-detect electrodes 28 and 30 left exposed by layer50 to be wider than the portions of working electrode 22 and counterelectrode 24 left exposed by layer 50.

[0062] In a preferred approach, dielectric layer 50 is applied byscreen-printing a dielectric material. A preferred dielectric materialcomprises a mixture of silicone and acrylic compounds, such as the“Membrane Switch Composition 5018” available from E.I. DuPont de Nemours& Co., Wilmington, Del.

[0063] In the next step, dielectric spacer layer 64 may be applied todielectric layer 50, as illustrated in FIG. 8. Spacer 64 may be appliedto dielectric layer 50 in a number of different ways. In a preferredapproach, spacer 64 is provided as a sheet large enough andappropriately shaped to cover multiple test strip structures. In thisapproach, the underside of spacer 64 may be coated with an adhesive tofacilitate attachment to dielectric layer 50 and base layer 18. Portionsof the upper surface of spacer 64 may also be coated with an adhesive inorder to provide adhesive layer 78 in each of the test strips 10.Various slots may be cut into or punched out of spacer 64 to shape itbefore spacer layer 64 is applied to dielectric layer 50. For example,as shown in FIG. 8, spacer 64 may have a slot 116 for each test stripstructure and a slot 118 that extends over multiple test stripstructures. In addition, spacer 64 may include adhesive sections 120 and122, with break 84 therebetween, for each test strip structure beingformed.

[0064] Spacer 64 is then positioned over base layer 18, as shown in FIG.8, and laminated to base layer 18 and dielectric layer 50. When spacer64 is appropriately positioned on base layer 18, exposed electrodeportions 54-62 are accessible through slot 116. Thus, slot 66 in teststrip 10 corresponds to that part of slot 116 that remains in test strip10 after the test strip structures are separated into test strips.Similarly, slot 118 in spacer 64 leaves contacts 32-38 and auto-onconductor 48 exposed after lamination.

[0065] Alternatively, spacer 64 could be applied in other ways. Forexample, spacer 64 may be injection molded onto base layer 18 anddielectric 50. Spacer 64 could also be built up on dielectric layer 50by screen-printing a dielectric material to the appropriate thickness.

[0066] Reagent layer 90 may then be applied to each test stripstructure. In a preferred approach, reagent layer 90 is applied bymicropipetting an aqueous composition onto exposed portion 54 of workingelectrode 22 and letting it dry to form reagent layer 90. A preferredaqueous composition has a pH of about 6 and contains 2 weight %polyvinyl alcohol, 0.1 M potassium phosphate, 0.05 weight % TritonX-100, 0.15 M potassium ferricyanide, 0.7% hydroxyethylcellulose (suchas NATROSOL®), and about 2500 units of glucose oxidase per mL.Alternatively, other methods, such as screen-printing, may be used toapply the composition used to form reagent layer 90.

[0067] A transparent cover 72 may then be attached to adhesive layer 78.As shown in FIG. 9, cover 72 (which is shown as transparent) may belarge enough to cover multiple test strip structures 102. Attachingcover 72 may complete the formation of the plurality of test stripstructures 102. The plurality of test strip structures 102 may then beseparated from each other to form a plurality of test strips 10, asdescribed above.

[0068] 3. The Meter and Removable Data Storage Device

[0069] To measure the glucose level in a blood sample, test strip 10 ispreferably used with a meter 200, as shown in FIGS. 10 and 11.Preferably, meter 200 has a size and shape to allow it to beconveniently held in a user's hand while the user is performing theglucose measurement. Meter 200 may include a front side 202, a back side204, a left side 206, a right side 208, a top side 210, and a bottomside 212. Front side 202 may include a display 214, such as a liquidcrystal display (LCD). Bottom side 212 may include a strip connector 216into which test strip is inserted to conduct a measurement.

[0070] Left side 206 of meter 200 may include a data connector 218 intowhich a removable data storage device 220 may be inserted, as describedin more detail below. Top side 210 may include one or more user controls222, such as buttons, with which the user may control meter 200. Rightside 208 may include a serial connector (not shown).

[0071]FIG. 12 shows a preferred embodiment of strip connector 216 inmore detail. Strip connector 216 includes a channel 230 with a flaredopening 231 for receiving test strip 10. Tabs 232 and 234 hang over theleft and right sides, respectively, of channel 230 at a predeterminedheight. This predetermined height is set to allow distal end 14 (in thinsection 94), but not proximal end 12 (in thick section 96), to beinserted into strip connector 216. In this way, the user may beprevented from improperly inserting test strip 10 into strip connector216.

[0072] Electrical contacts 236 and 238 are disposed in channel 230behind tabs 232 and 234, and electrical contacts 240-246 are disposed inchannel 230 behind electrical contacts 236 and 238. When distal end 14of test strip 10 is properly inserted into strip connector 216,electrical contacts 236-246 contact electrical contacts 32-38 andauto-on conductor 48 to electrically connect test strip 10 to meter 200.In particular, electrical contacts 236 and 238 contact electricalcontacts 32 and 34, respectively, to electrically connect workingelectrode 22 and counter electrode 24 to meter 200. Electrical contacts240 and 242 contact electrical contacts 36 and 38, respectively, toelectrically fill-detect electrodes 28 and 30 to meter 200. Finally,electrical contacts 244 and 246 electrically connect auto-on conductor48 to meter 200.

[0073] Meter 200 may use data from removable data storage device 220 tocalculate glucose levels in blood samples measured by meter 200.Specifically, data storage device 220 may be associated with a lot oftest strips and may store one or more parameters that meter 200 may usefor that lot. For example, data storage device 220 may store one or morecalibration parameters that meter 200 may use to calculate the glucoselevel from an averaged current measurement. The calibration parametersmay include temperature corrections. Data storage device 220 may alsostore other information related to the lot of test strips and the meter,such as a code identifying the brand of test strips, a code identifyingthe model of meter to be used, and an expiration date for the lot oftest strips. Data storage device 220 may also store other informationused by meter 206, such as the duration of the fill timer and theincubation timer, the voltages to use for the “Drop Level 1,” “Fill,”and “Assay Excitation Level 2” voltages, one or more parameters relatingto the number of current measurements to make, and one or moreparameters specifying how the meter should average the currentmeasurements, as described in more detail below. Data storage device 220may also store one or more checksums of the stored data or portions ofthe stored data.

[0074] In a preferred approach, before a given lot of test strips areused with meter 200, the removable data storage device 220 associatedwith that given lot is first inserted into data connector 218. Meter 200may then load the relevant data from data storage device 220 into aninternal memory when a test strip is inserted into strip connector 216.With the relevant data stored in its internal memory, meter 200 nolonger needs data storage device 220 to measure glucose levels usingtest strips in the given lot. Thus, removable data storage device 220may be removed from meter 200 and may be used to code other meters. Ifdata storage device 220 is retained in meter 200, meter 200 may nolonger access it but instead use the data stored in its internal memory.

[0075] With reference to FIG. 13, removable data storage device 220 mayinclude a memory chip 250 mounted on a circuit board 252, which, inturn, is mounted to a carrier 254. Memory chip 250 stores the data in apredetermined format. Preferably, memory chip 250 includes anon-volatile memory, so as to retain the stored data when un-powered.For example, memory chip 250 may be an electronically erasableprogrammable read only memory (EEPROM) chip. Such EEPROM chips cantypically be written to many times (e.g., one million write cycles, ormore) so that it does not wear out over the life cycle of usage.

[0076] Memory chip 250 may be electrically connected to a plurality ofelectrical contacts on circuit board 252. These electrical contacts mayinclude a voltage supply contact 256, a ground contact 258, a datainput/output contact 260, and a clock contact 262. In this way, when theappropriate voltage is applied to voltage supply 256, relative to groundcontact 258, data may be synchronously read from or written to memorychip 250 using data input/output contact 260 and clock contact 262. Asdescribed in more detail below, ground contact 258 may be longer thanthe other electrical contacts 256, 260, and 262, for greaterreliability.

[0077] Carrier 254 may be made out of a material such as plastic and mayinclude a distal end 264 and a proximal end 266. Distal end 264 isintended to be inserted into data connector 218. Proximal end 266 mayinclude a flange 268 to allow a user's fingers to grip removable datastorage device 220 for either insertion into or removal from dataconnector 218. Carrier 254 may include an opening 270 through whichelectrical contacts 256-262 are accessible. Thus, when data storagedevice 220 is properly inserted into data connector 218, electricalcontacts 256-262 on circuit board 252 contact corresponding electricalcontacts 272-278 (shown in FIG. 10), respectively, in data connector218. In this way, meter 200 may become electrical connected to memorychip 250 to read the data stored therein.

[0078] Carrier 254 and data connector 218 may be “keyed” so thatremovable data storage device 220 may be inserted into connector 218 inonly one orientation. For example, carrier 254 may include awedge-shaped corner 282 and connector 218 may include a wedge-shapedopening 284 for receiving wedge-shaped corner 282. As a result, datastorage device 220 may fit into data connector 218 only when oriented sothat wedge-shaped corner 282 is received in wedge-shaped opening 284.Beneficially, this keying may cue the user as to the proper insertionorientation and may prevent damage that could be caused by improperinsertion.

[0079] Another feature of removable data storage device 220 that mayenhance its reliability is the greater length of ground contact 258.Specifically, circuit board 252 is mounted to carrier 254 such thatground contact 258 extends closer to distal end 264 (i.e., the endinserted into data connector 218) than the other electrical contacts256, 260, and 262. As a result, ground contact 258 is the firstelectrical contact on circuit board 252 to make electrical contact withmeter 200 when data storage device 220 is inserted into data connector218 and the last electrical contact to break electrical contact withmeter 200 when data storage device 220 is removed. This prevents memorychip 250 from being powered in an unintended operating mode that may notbe reliable, e.g., the supply voltage from meter 200 being applied tomemory chip 250 through voltage supply contact 256 without memory chip250 also being connected to ground through ground contact 258.

[0080] 4. The Use of the Test Strip with the Meter

[0081] In order to save power, meter 200 is preferably in a low power“sleep” mode most of the time. However, meter 200 may “wake up” andenter an active mode when certain situations occur. For example,actuating one or more of the user controls 222 may cause meter 200 towake up, as may attempting to use serial port 416 for data transfer.Preferably, inserting either test strip 10 or a check strip into meter200 also wakes it up. Meter 200 may then determine whether the insertedstrip is a test strip or a check strip. The flow chart of FIG. 14illustrates this process.

[0082] At first, meter 200 is in a low power sleep mode, as indicated bystep 300. Then, either a test strip or check strip is inserted intometer 200, as indicated by step 302. The insertion causes the auto-onconductor on the strip (e.g., auto-on conductor 48 on test strip 10) tobridge auto-on contacts 244 and 246 in meter 200. As a result, anauto-on current starts to flow through auto-on contacts 244 and 246 andthrough the auto-on conductor. This auto-on current causes meter 200 towake up and enter an active mode, as indicated by step 304.

[0083] In this active mode, meter 200 measures the voltage drop acrossthe auto-on conductor, as indicated by step 306. In a preferredapproach, the resistance of the auto-on conductors in test strips issignificantly different than in check strips. Thus, meter 200 maydetermine whether the strip inserted into it is a test strip or a checkstrip based on the auto-on voltage drop. For example, the auto-onconductors in test strips may have a substantially lower resistance thanin check strips. Accordingly, meter 200 may compare the auto-on voltagedrop to a predetermined threshold value, as indicated by step 308. Ifthe auto-on voltage drop is less than the predetermined threshold value,then meter 200 identifies the strip as a test strip and performs a teststrip sequence, as indicated by step 310. On the other hand, if theauto-on voltage drop is greater than the predetermined threshold value,then meter 200 identifies the strip as a check strip and performs acheck strip sequence, as indicated by step 312.

[0084] The flowchart of FIG. 15 illustrates a preferred the check stripsequence. A check strip may have electrical contacts near its distal end(in addition to the auto-on conductor) that are similar to electricalcontacts 32-38 on test strip 10, except that the electrical contacts onthe check strip may be connected to resistors, with predeterminedresistances, rather than to actual electrodes. Thus, when a check stripis inserted into meter 200, electrical contacts 236 and 238 may contact“working electrode” and “counter electrode” contacts on the check stripthat are actually connected via a first resistor in the check strip.Similarly, electrical contacts 240 and 242 may contact “fill-detect”contacts on the check strip that are actually connected via a secondresistor in the check strip.

[0085] As summarized in FIG. 15, meter 200 may perform the check stripsequence by measuring the currents through the first and secondresistors in the check strip to determine if the measured values fallwithin acceptable ranges. If the measured current values do not fallwithin the acceptable ranges, then there may be a problem with meter200. Thus, meter 200 may first measure the current through working andcounter electrode contacts 236 and 238 to obtain a measured currentvalue through the first resistor, as indicated by step 314. Meter 200then determines if this measured current value is within the acceptablerange, as indicated by step 316. If the measured current value is notwithin the acceptable range, then meter 200 indicates a failure status,as indicated by step 318. To indicate the failure status, meter 200 maydisplay a message or an icon on display 214 and/or provide some otheruser-discernible failure indication.

[0086] If the measured current through the first resistor is within theacceptable range, then meter 200 may also measure the current throughfill-detect electrode contacts 240 and 242 to obtain a measured currentvalue through the second resistor, as indicated by step 320. Then, meter200 determines whether this measured current value is within anacceptable range, as indicated by step 322. If the measured currentvalue is not within the acceptable range, then meter 200 indicates afailure status, as indicated by step 324. If the measured current valueis within the acceptable range, then meter 200 may indicate anoperational status. For example, meter 200 may display an “OK” icon ondisplay 214.

[0087] As noted above, if the meter 200 detects a test strip, then meter200 performs a test strip sequence. As a first phase of the test stripsequence, meter 200 may validate the working, counter, and fill-detectelectrodes by determining whether the impedances between them aresufficiently high. This process is illustrated in the flow chart of FIG.16.

[0088] As indicated by step 328, meter 200 may apply a predeterminedfirst validation voltage, e.g., the “Drop Level 1” voltage, betweenworking and counter electrodes 22 and 24 and measure any resultingcurrent flowing through working electrode 22. The first validationvoltage should result in little or no current, because there should notbe a low-impedance pathway between working electrode 22 and counterelectrode 24. Thus, meter 200 may check whether the resulting current isbelow a maximum allowable value, as indicated by step 330. If theresulting current is above the maximum value, then meter may indicate afailure status, as indicated by step 332.

[0089] Otherwise, meter 200 may proceed with the test strip sequence andapply a predetermined second validation voltage, e.g., the “Fill”voltage, across fill-detect electrodes 28 and 30 and measure anyresulting current flowing through fill-detect anode 28, as indicated bystep 334. The second validation voltage should also result in little orno current, because there should not be any low-impedance pathwaysbetween any of the electrodes. Thus, meter 200 may check whether theresulting current is below a maximum allowable value, as indicated bystep 336. If the resulting current is above this maximum value, thenmeter may indicate a failure status, as indicated by step 338.Otherwise, meter 200 may indicate that a blood sample may be applied totest strip 10. For example, meter 200 may display a message or an iconon display 214 and/or provide some other user-discernible indication.

[0090] Meter 200 may perform the measurement of step 334 at the sametime it performs the measurement of step 328. Thus, meter 200 may applythe “Drop Level 1” voltage between working and counter electrodes 22 and24, measuring any resulting current through working electrode 22, whileat the same time applying the “Fill” voltage between fill-detectelectrodes 28 and 30 and measuring any resulting current throughfill-detect anode 28.

[0091] If the electrodes are validated, meter 200 may then proceed withthe process illustrated in the flow chart of FIG. 17. To detect when theuser applies the blood sample, meter 200 applies “Drop Level 1” voltageacross working electrode 22 and counter electrode 24 and measures anyresulting current flowing between these electrodes, as indicated by step342. Preferably, the “Drop Level 1” voltage is less than the redoxpotential of the chemistry used in reagent layer 90. At step 344, theuser applies a blood sample to test strip 10. More particularly, theuser applies the blood sample to the opening of sample chamber 88 atproximal end 12, as shown in FIG. 3. As noted above, sample chamber 88is dimensioned to draw the blood sample into it by capillary action. Asthe blood sample moves into sample chamber 88, it will eventually bridgeworking electrode 22 and counter electrode 24, thereby providing anelectrically conductive pathway between them. Thus, meter 200 determinesthat a blood sample is present in sample chamber 88 when the resultingcurrent reaches a predetermined threshold value or series of thresholdvalues with an overall positive magnitude change, as indicated by step346. When meter 200 detects the blood sample in this way, meter 200disconnects working and counter electrodes 22 and 24, putting them in ahigh impedance state relative to fill-detect electrodes 28 and 30, andmeter 200 starts a fill timer and an incubation timer, as indicated bystep 348. Before meter 200 puts working and counter electrodes 22 and 24in the high impedance state, meter 200 may first ground them todischarge stored charges.

[0092] The fill timer sets a time limit for the blood sample to traversereagent layer 90 and reach fill-detect electrodes 28 and 30. Theincubation timer sets a delay period to allow the blood sample to reactwith reagent layer 90. Once meter 200 starts the fill timer running,meter 200 applies a voltage, the “Fill” voltage, between fill-detectelectrodes 28 and 30 and measures the resulting current flowing betweenthese electrodes, as indicated by step 350. As indicated by step 352,meter 200 checks whether the resulting current reaches a predeterminedthreshold value or a series of thresholds with an overall positivemagnitude change before the fill timer elapses. Preferably, the currentthreshold(s) are set so that meter 200 can determine whether sufficientsample has reached fill-detect electrodes 28 and 30 and whether thesample has become mixed with the chemical constituents in reagent layer90.

[0093] If the current does not reach the required value, then there maybe some problem with test strip 10. For example, there may be a blockagein sample chamber 88. There may be an inadequate amount of sample. Theremay be no reagent layer, or the chemical constituents reagent layer mayhave failed to mix with the blood sample. Any of these problems may makethe glucose measurement unreliable. Accordingly, if the fill timerelapses without a sufficient current through fill-detect electrodes 28and 30, meter 200 may indicate a failure status, as indicated by step354. Meter 200 may indicate this failure status by displaying an errormessage or icon on display 214 and/or by providing some otheruser-discernible indication. The duration of the fill timer may, forexample, be in the range of 2 to 6 seconds.

[0094] If however, meter 200 detects sufficient current throughfill-detect electrodes 28 and 30 before the fill timer elapses, thenmeter 200 may proceed with the glucose measurement process. As indicatedby step 356, meter 200 may provide an indication to the user that meter200 has detected adequate sample mixed with the chemical constituents ofreagent layer 90. For example, meter 200 may beep, display a message oricon on display 214, or provide some other user-discernible indication.Preferably, meter 200 also disconnects fill-detect electrodes 28 and 30,bringing them to a high impedance state relative to working electrode 22and counter electrode 24. Meter 200 may ground fill-detect electrodes 28and 30 before putting them into the high impedance state in order todischarge stored charges. Meter 200 then waits for the incubation timerto elapse, as indicated by step 358, in order to allow sufficient timefor the blood sample to react with reagent layer 90. The incubationtimer may, for example, take about 2 seconds to about 10 seconds toelapse, depending on the implementation. In a preferred embodiment, theincubation timer lasts about 5 seconds.

[0095] When the incubation timer elapses, meter 200 applies the “AssayExcitation Level 2” voltage between working electrode 22 and counterelectrode 24 and measures the resulting current flowing between theseelectrodes, as indicated by step 360. Preferably, meter 200 measures theresulting current at a fixed sampling rate throughout a measurementperiod, to obtain a plurality of current measurements. The measurementperiod may last from about 5 seconds to about 15 seconds, depending onthe implementation. In a preferred embodiment, the measurement periodlasts about 5 seconds.

[0096] Meter 200 then determines the glucose level in the blood samplefrom the current measurements, as indicated by step 362. In a preferredapproach, meter 200 may average the current measurements to obtain anaverage current value at a predetermined point of time during themeasurement period. Meter 200 may then use the calibration data obtainedfrom removable data storage device 220 and stored in its internal memoryto calculate the glucose level from the average current value. Meter 200may also take a temperature reading and use the temperature reading tocorrect the measured glucose level for temperature dependence. Inaddition, meter 200 may check the validity of the current measurementsby checking that the measured current decreases over time, as expected.

[0097] For example, in a preferred embodiment, meter 200 may take apredetermined number of current measurements (m₁ . . . m_(M)) in 0.1second time intervals. The predetermined number, M, may, for example,range from 50 to 150, and it may be a parameter specified in removabledata storage device 220. The meter may then average every n currentmeasurements to provide a plurality of data points (d₁ . . . d_(N)).Thus, if n is equal to 3, the meter would calculate d₁ by averaging m₁,m₂, and m₃, and would calculated d₂ by averaging m₂, m₃, and m₄. Theaveraging parameter, n, may be a parameter specified in removable datastorage device 220. One of the data points may then be selected as thecenter point for another level of averaging, in which the meter averagestogether the data points around and including the center point toprovide a meter reading, X. Thus, if d₂ is selected as the center point,then the meter may average d₁, d₂, and d₃ together to calculate themeter reading, X. Removable data storage device 220 may store aparameter that specifies which of the data points to use as the centerpoint for calculating the meter reading, X. Meter 200 then calculatesthe glucose level, Y, from the meter reading, X, and one or morecalibration parameters, which may be specified in removable data storagedevice 220. For example, in a preferred embodiment, meter 200 may usethree calibration parameters, a, b, and c, to calculate Y from theexpression a+bX+c/X.

[0098] The calculated glucose level, Y, may not be temperaturecorrected, however. To correct for temperature, meter 200 may apply oneor more temperature correction parameters, which may be specified inremovable data storage device 220. For example, in a preferredembodiment, the temperature-corrected glucose level may be calculatedfrom the expression A+BT+CYT+DY, where A, B, C, and D are temperaturecorrection parameters and T is a measured temperature. The calibrationparameters A, B, C, and D may be specified in removable data storagedevice 220. In other embodiments, the temperature correction may useonly a single parameter, S, which may be specified in removable datastorage device 220. For example, the temperature-corrected glucose levelmay be calculated from the expression Y/[(1+S(T−21)].

[0099] If the current measurements appear valid, then meter 200 displaysthe glucose level, typically as a number, on display 214, as indicatedby step 364. Meter 200 may also store the measured glucose level, with atimestamp, in its internal memory.

[0100] 5. Meter Electronics

[0101]FIG. 18 shows, in simplified form, the electronic components ofmeter 200, in accordance with a preferred embodiment. Meter 200 mayinclude a microcontroller 400 that controls the operation of meter 200in accordance with programming, which may be provided as software and/orfirmware. Microcontroller 400 may include a processor 402, a memory 404,which may include read-only memory (ROM) and/or random access memory(RAM), a display controller 406, and one or more input/output (I/O)ports 408. Memory 404 may store a plurality of machine languageinstructions that comprises the programming for controlling theoperation of meter 200. Memory 404 may also store data. Processor 402executes the machine language instructions, which may be stored inmemory 404 or in other components, to control microcontroller 400 and,thus, meter 200. In particular, processor 402 executes the storedmachine language instructions so that meter 200 performs the functionssummarized in the flowcharts of FIGS. 14-17 and described above.

[0102] Microcontroller 400 may also include other components under thecontrol of processor 402. For example, microcontroller 400 may include adisplay controller 406 to help processor 402 control display 214. In apreferred embodiment, display 214 is an LCD and display controller 406is an LCD driver/controller. Microcontroller may also include I/O ports408, which enable processor 402 to communicate with components externalto microcontroller 400. Microcontroller 400 may also one or more timers410. Processor 402 may use timers 410 to measure the fill time period,incubation time period, and other time periods described above.Microcontroller 400 may be provided as an integrated circuit, such asthe HD64F38024H, available from Hitachi.

[0103] Microcontroller 400 is preferably connected to components thatprovide a user interface. The components that make up the user interfaceof meter 200 may include display 214, a beeper 412, and user controls222. Microcontroller 400 may display text and/or graphics on display214. Microcontroller may cause beeper 412 to beep, such as to indicatethat adequate sample (mixed with the chemistry of reagent layer 90) hasreached fill-detect electrodes 28 and 30, as described above.Microcontroller 400 may also be connected to other components, such asone or more light-emitting diodes (LEDs), to provide user-discernibleindications, which may be visible, audible, or tactile. Microcontroller400 may receive user input from user controls 222. In a preferredembodiment, user controls 222 consists of a plurality of discreteswitches. However, user controls 222 may also include a touch screen orother components with which a user can provide input to meter 200.

[0104] Microcontroller 400 may have access to one or more memoriesexternal to it, such as an EEPROM 414. In a preferred embodiment,microcontroller 400 stores the measured glucose levels, and the timesand dates the glucose measurements occurred, in EEPROM 414. By usinguser controls 222, the user may also be able to cause microcontroller400 to display one or more of the glucose measurements stored in EEPROM414 on display 214. Microcontroller 400 may also be connected to aserial port 416, through which the user can access the glucosemeasurements stored in EEPROM 414. Microcontroller 400 may use atransmit line, “TX,” to transmit signals to serial port 416 and may usea receive line, “RX,” to receive signals from serial port 416.

[0105] EEPROM 414 may also store the data from removable data storagedevice 220. In this regard, FIG. 18 shows how electrical contacts272-278 of data connector 216 are connected inside of meter 200. Contact272 is connected to a source of power, which may be throughmicrocontroller 400. In this way, microcontroller 400 can do “powermanagement,” powering removable data storage 220, through contact 272,only when necessary, e.g., when downloading data from removable datastorage device 220. Contact 274 is connected to ground. Contacts 276 and278 are connected to data input/output and clock outputs, respectively,of microcontroller 400. In this way, microcontroller 400 may downloadthe data from data storage device 220, when connected to data connector216, and store the data in EEPROM 414.

[0106] In a preferred embodiment, meter 200 also includes a dataacquisition system (DAS) 420 that is digitally interfaced withmicrocontroller 400. DAS 420 may be provided as an integrated circuit,such as the MAX1414, available from Maxim Integrated Products,Sunnyvale, Calif.

[0107] DAS 420 includes one or more digital-to-analog converters (DACs)that generate analog voltages in response to digital data frommicrocontroller 400. In particular, DAS 420 includes “Vout1” and “FB1”terminals, which DAS 420 uses to apply analog voltages generated by afirst DAC to working electrode 22, when test strip 10 is inserted instrip connector 216. Similarly, DAS 420 includes “Vout2” and “FB2”terminals, which DAS 420 uses to apply analog voltages generated by asecond DAC to fill-detect anode 28, when test strip 10 is inserted instrip connector 216. The one or more DACs in DAS 420 generate analogvoltages based on digital signals provided by microcontroller 400. Inthis way, the voltages generated by the one or more DACs may be selectedby processor 402.

[0108] DAS 420 also includes one or more analog-to-digital converters(ADCs) with which DAS 420 is able to measure analog signals. Asdescribed in more detail below, DAS 420 may use one or more ADCsconnected to the “Vout1” and “Vout2” terminals to measure currents fromworking electrode 22 and counter electrode 24, respectively, when teststrip 10 is inserted in strip connector 216. DAS 420 may also includeone or more other terminals through which the ADCs may measure analogsignals, such as the “Analog In1” and “Analog In2” terminals shown inFIG. 18. DAS 420 may use the “Analog In1” terminal to measure thevoltage across the auto-on conductor in a test strip or check strip thatis connected to strip connector 216. The “Analog In2” terminal may beconnected to a thermistor, RT1, to enable DAS 420 to measuretemperature. In particular, DAS 420 may supply a reference voltage,V_(ref), through a voltage divider that includes thermistor, RT1, andanother resister, R_(d). DAS 420 may use the “Analog In2” terminal tomeasure the voltage across thermistor, RT1. DAS 420 transfers thedigital values obtained from the one or more ADCs to microcontroller400, via the digital interface between these components.

[0109] Preferably, DAS 420 has at least two modes of operation, a“sleep” or low-power mode and an “active” or run mode. In the activemode, DAS 420 has full functionality. In the sleep mode, DAS 420 hasreduced functionality but draws much less current. For example, whileDAS 420 may draw 1 mA or more in the active mode, DAS 420 may draw onlymicroamps in the sleep mode. As shown in FIG. 18, DAS 420 may include“Wake-up1,” “Wake-up2,” and “Wake-up3” inputs. When appropriate signalsare asserted at any of these “Wake-up” terminals, DAS 420 may wake upfrom the sleep mode, enter the active mode, and wake up the rest ofmeter 200, as described in more detail below. In a preferred embodiment,the “Wake-up” inputs are active-low inputs that are internally pulled upto the supply voltage, V_(CC). As described in more detail below,inserting the auto-on conductor in either a test strip or check stripinto strip connector 216 causes the “Wake-up1” input to go low and,thereby, causing DAS 420 to enter the active mode. In addition, the“Wake-up2” input may be connected to one or more of user controls 222.In this way, the user's actuation of at least certain of user controls222 causes DAS 420 to enter the active mode. Finally, the “Wake-up3”input may be connected to serial port 416, e.g., via receive line, “RX.”In this way, attempting to use serial port 416 for data transfer maywake up DAS 420 and, hence, meter 200.

[0110] As shown in FIG. 18, DAS 420 includes several terminals that areconnected to microcontroller 400. DAS 420 includes one or more “DataI/O” terminals, through which microcontroller 400 may write digital datato and read digital data from DAS 420. DAS 420 also includes a “ClockIn” terminal that receives a clock signal from microcontroller 400 tocoordinate data transfer to and from the “Data I/O” terminals. DAS 420may also include a “Clock Out” terminal through which DAS 420 may supplya clock signal that drives microcontroller 400. DAS 420 may generatethis clock signal by using a crystal 422. DAS 420 may also generate areal time clock (RTC) using crystal 422.

[0111] DAS 420 may also include other terminals through which DAS 420may output other types of digital signals to microcontroller 400. Forexample, example DAS 420 may include a “Reset” terminal, through whichDAS 420 may output a signal for resetting microcontroller 400. DAS 420may also include one or more “Interrupt Out” terminals, which DAS 420may use to provide interrupt signals to microcontroller 400. DAS 420 mayalso include one or more “Data Ready” inputs that DAS 420 may use tosignal microcontroller 400 that DAS 420 has acquired data, such as froman analog-to-digital conversion, which is ready to be transferred tomicrocontroller 400.

[0112] As shown in FIG. 18, meter 200 may include a power source, suchas one or more batteries 424. A voltage regulator 426 may provide aregulated supply voltage, V_(CC), from the voltage supplied by batteries424. The supply voltage, V_(CC), may then power the other components ofmeter 200. In a preferred embodiment, voltage regulator 426 is a step-upDC-to-DC voltage converter. Voltage regulator 426 may be provided as anintegrated circuit and other components, such as an inductor,capacitors, and resistors. The integrated circuit may, for example, be aMAX1724, available from Maxim Integrated Products, Sunnyvale, Calif.

[0113] Preferably, voltage regulator 426 has a shutdown mode, in whichit provides only an unregulated output voltage. DAS 420 may include a“Shutdown” terminal through which DAS 420 may control voltage regulator426. In particular, when DAS 420 enters the sleep mode, DAS 420 mayassert a low level signal at its “Shutdown” terminal, causing voltageregulator 426 to enter the shutdown mode. When DAS 420 enters the activemode, it asserts a high level signal at its “Shutdown” terminal,allowing voltage regulator 426 to operate normally.

[0114]FIG. 18 also shows how electrical contacts 236-246 of stripconnector 216 are connected in meter 200. Contacts 236 and 238, whichare electrically connected to working electrode 22 and counter electrode24, respectively, when test strip 10 is inserted in strip connector 216,are connected as follows. Contact 236, for working electrode 22, isconnected to the “FB1” terminal of DAS 420 and connected via a resistor,RF1, to the “Vout1” terminal of DAS 420. Contact 238, for counterelectrode 24, is connected to a switch 428. Switch 428 allows contact238 (and, hence, counter electrode 24) to be connected to ground or leftin a high impedance state. Switch 428 may be digitally controlled bymicrocontroller 400, as shown in FIG. 18. With counter electrode 24connected to ground, DAS 420 may use the “Vout1” and “FB1” terminals toapply voltages to working electrode 22 (relative to counter electrode24) and to measure the current through working electrode 22.

[0115] Contacts 240 and 242, which are electrically connected tofill-detect anode 28 and fill-detect cathode 30, respectively, when teststrip 10 is inserted in strip connector 216, are connected as follows.Contact 240, for fill-detect anode 28, is connected to the “FB2”terminal of DAS 420 and connected via a resistor, RF2, to the “Vout2”terminal of DAS 420. Contact 242, for fill-detect cathode 30, isconnected to a switch 430. Switch 430 allows contact 242 (and, hence,fill-detect cathode 30) to be connected to ground or left in a highimpedance state. Switch 430 may be digitally controlled bymicrocontroller 400, as shown in FIG. 18. With fill-detect cathode 30connected to ground, DAS 420 may use the “Vout2” and “FB2” terminals toapply voltages to fill-detect anode 28 (relative to fill-detect cathode30) and to measure the current through fill-detect anode 28.

[0116] Switches 428 and 430 may be single-pole/single-throw (SPST)switches, and they may be provided as an integrated circuit, such as theMAX4641, available from Maxim Integrated Products, Sunnyvale, Calif.However, other configurations for switches 428 and 430 could be used.

[0117] Contacts 244 and 246, which are electrically connected to theauto-on conductor when a test strip or check strip is inserted intostrip connector 216, are connected as follows. Contact 246 is connectedto ground or other reference potential. Contact 244 is connected to the“Analog In1” and “Wake-up1” terminals of DAS 420 and to microcontroller400. As described in more detail below, the presence of the auto-onconductor drives the “Wake-up1” terminal low, thereby waking up DAS 420and causing it to enter an active mode. DAS 420 uses the “Analog In1”terminal to measure the voltage across the auto-on conductor. By virtueof its connection to contact 244, microcontroller 400 is able todetermine whether the auto-on conductor is present, and, thus, whethereither a test strip or check strip is connected to strip connector 216.

[0118]FIG. 19 shows in greater detail the functional aspects of theconnections between meter 200 and electrodes 22, 24, 28, and 30, whentest strip 10 is inserted in strip connector 216. As shown in FIG. 19,DAS 420 functionally includes an amplifier 440 for working electrode 22and an amplifier 442 for fill-detect anode 28. More particularly, theoutput of amplifier 440 is connected to working electrode 22, via the“Vout1” terminal and resistor, RF1, and the inverting input of amplifier440 is connected to working electrode 22, via the “FB1” terminal.Similarly, the output of amplifier 442 is connected to fill-detect anode28, via the “Vout2” terminal and resistor, RF2, and the inverting inputof amplifier 442 is connected to fill-detect anode 28, via the “FB2”terminal.

[0119] To generate selected analog voltages to apply to workingelectrode 22 and fill-detect electrode 28, DAS 420 includes a first DAC444 and a second DAC 446, respectively. DAC 444 is connected to thenon-inverting input of amplifier 440, and DAC 446 is connected to thenon-inverting input of amplifier 442. In this way, amplifier 440 appliesa voltage to the “Vout1” terminal, such that the voltage at workingelectrode 22, as sensed at the inverting input of amplifier 440, isessentially equal to the voltage generated by DAC 444. Similarly,amplifier 442 applies a voltage to the “Vout2” terminal, such that thevoltage at fill-detect electrode 28, as sensed at the inverting input ofamplifier 442, is essentially equal to the voltage generated by DAC 446.

[0120] To measure the currents through working electrode 22 andfill-detect anode 28, DAS 420 includes an ADC 448 and multiplexers(MUXes) 450 and 452. MUXes 450 and 452 are able to select the inputs ofADC 448 from among the “Vout1,” “FB1,” “Vout2,” and “FB2” terminals.

[0121] DAS 420 may also include one or more buffers and/or amplifiers(not shown) between ADC 448 and MUXes 450 and 452. To measure thecurrent through working electrode 22, MUXes 450 and 452 connect ADC 448to the “Vout1” and “FB1” terminals to measure the voltage acrossresistor, RF1, which is proportional to the current through workingelectrode 22. To measure the current through fill-detect electrode 28,MUXes 450 and 452 connect ADC 448 to the “Vout2” and “FB2” terminals tomeasure the voltage across resistor, RF2, which is proportional to thecurrent through fill-detect anode 28.

[0122] As noted above, meter 200 preferably includes switches 428 and430 that may be used to bring counter electrode 24 and fill-detectcathode 30, respectively, into a high impedance state.

[0123] It is also preferable for meter 200 to be able to bring workingelectrode 22 and fill-detect anode 28 into a high impedance state aswell. In a preferred embodiment, this may be achieved by DAS 420 beingable to bring terminals “Vout1,” “FB1,” “Vout2,” and “FB2” into highimpedance states. Accordingly, DAS 420 may effectively include switches454, 456, 458, and 460, as shown in FIG. 19. Although switches 428, 430,and 454-460 may be SPST switches, as shown in FIG. 19, other types ofswitches, such as single pole-double throw (SPDT) switches, may be used,and the switches may be arranged in other ways, in order to providemeter 200 with the ability to select one pair of electrodes (either theworking and counter electrode pair or the fill-detect electrode pair)and leave the other pair of electrodes in a high impedance state. Forexample, a pair of SPDT switches may be used, with one SPDT switchselecting which of working electrode 22 and fill-detect 28 to connect toDAS 420 and the other SPDT switch selecting which of counter electrode24 and fill-detect cathode to connect to ground. In other cases, meter200 may not be configured to bring all of the electrodes into highimpedance states. For example, in some embodiments, meter 200 may notinclude switch 428, with the result that counter electrode 24 is alwaysconnected to ground when test strip 10 is inserted in strip connector216.

[0124]FIG. 20 shows in greater detail the functional aspects of theconnections between meter 200 and the auto-on conductor when either atest strip or a check strip is inserted in strip connector 216. As shownin FIG. 20, the auto-on conductor provides an effective resistance,R_(auto), between contacts 244 and 246 of strip connector 216. Withinmeter 200, contact 244 is connected to the source voltage, V_(CC),through an effective resistance, R_(S). For example, the “Wake-up1”terminal of DAS 420, to which contact 244 is connected, may beinternally pulled up to V_(cc), through an effective resistance, R_(S).Accordingly, when either a test strip or a check strip is inserted intostrip connector 216, such that the auto-on conductor bridges contacts244 and 246, a current flows through the auto-on resistor and a voltagedrop develops between contacts 244 and 246. The magnitude of thisauto-on voltage drop depends on the relative magnitudes of R_(auto) andR_(S). Preferably, R_(auto) is chosen sufficiently low for the teststrips and check strips, relative to R_(S), such that the auto-onvoltage is less than the logic low voltage (which may be about 0.8volts) used in meter 200. It is also preferable for R_(auto) to besubstantially different in test strips and check strips, so that meter200 may determine the strip type from the auto-on voltage drop. Forexample, if R_(S) is about 500 kΩ, then R_(auto) may be less than about20 Ωin a test strip and may be approximately 20 kΩ in a check strip. Inthis way, microcontroller 400 may determine that either a test strip orcheck strip is inserted in strip connector 216 by sensing a logic lowvoltage at contact 244.

[0125] DAS 420 also senses the auto-on voltage drop and uses it to wakeup meter 200 and to determine the strip type, i.e., whether a test stripor a check strip has been inserted into strip connector 216. In the caseof a test strip, DAS 420 may also confirm that the test strip has beenproperly inserted into strip connector 216.

[0126] DAS 420 may include wake-up logic 462, which senses the voltageat the “Wake-up1” terminal, via one or more buffers and/or amplifiers,such as buffer 464. DAS 420 also includes ADC 448, which can measure thevoltage at the “Analog In1” terminal, via one or more buffers and/oramplifiers, such as buffer 466. Although not shown in FIG. 20, MUXes 450and 452 may be connected between buffer 466 and ADC 448.

[0127] When no strip is present in strip connector 216, contact 244(and, thus, the “Wake-up1” terminal) is at a high voltage, at or nearV_(CC). However, when either a test strip or a check strip is insertedin strip connector 216, the auto-on conductor drives the voltage at the“Wake-up1” terminal low, as described above. Wake-up logic 462 sensesthe voltage at the “Wake-up1” terminal going low and, in response,initiates a wake-up sequence to bring DAS 420 into an active mode. Aspart of this wake-up sequence, wake-up logic 462 may cause DAS 420 toassert a signal at its “Shutdown” terminal to turn on voltage regulator426. Wake-up logic 462 may also cause DAS 420 to generate signals towake up microcontroller 400. For example, wake-up logic 462 may causeDAS 420 to assert a clock signal through its “Clock Out” terminal, areset signal through its “Reset” terminal, and an interrupt signalthrough its “Interrupt Out” terminal to activate microcontroller 400.

[0128] Though not shown in FIG. 20, wake-up logic 462 may also sense thevoltages at the “Wake-up1” and “Wake-up2” terminals and, in response toa voltage at one of these terminals going low, may initiate a wake-upsequence similar to that described above.

[0129] When DAS 420 enters the active mode, it also determines the typeof strip inserted into strip connector 216. In particular, ADC 448measures the voltage at the “Analog In1” terminal. DAS 420 then reportsthe measured voltage to microcontroller 400. Based on this information,microcontroller 400 then initiates either a test strip sequence or acheck strip sequence, as described above. Throughout either sequence,microcontroller 400 may periodically check the voltage at contact 244 tomake sure that the strip is still inserted in strip connector 216.Alternatively, an interrupt may notify microcontroller 400 of a voltageincrease at contact 244 caused by removal of the strip.

[0130] In this way, the auto-on voltage drop developed across theauto-on conductor performs several functions in meter 200. First, theauto-on voltage wakes up meter 200 from a sleep mode to an active mode.Second, meter 200 determines the strip type from the magnitude of theauto-on voltage. Third, the auto-on voltage lets meter 200 know that thestrip is still inserted in strip connector 216, as meter 200 proceedswith either the test strip or check strip sequence.

6. CONCLUSION

[0131] Preferred embodiments of the present invention have beendescribed above. Those skilled in the art will understand, however, thatchanges and modifications may be made to these embodiments withoutdeparting from the true scope and spirit of the invention, which isdefined by the claims.

1. A test strip for measuring glucose in a blood sample, said test stripcomprising: a first insulating sheet, said first insulating sheet havinga proximal end and a distal end, said proximal end being narrower thansaid distal end; at least four electrodes disposed on said firstinsulating sheet, said at least four electrodes including a workingelectrode, a counter electrode, a fill-detect anode, and a fill-detectcathode; a plurality of electrical contacts disposed on said firstinsulating sheet, said plurality of electrical contacts including aworking electrode contact, a counter electrode contact, a fill-detectanode contact, and a fill-detect cathode contact; a plurality ofconductive traces disposed on said first insulating sheet, saidplurality of conductive traces electrically connecting said workingelectrode to said working electrode contact, said counter electrode tosaid counter electrode contact, said fill-detect anode to saidfill-detect anode contact, said fill-detect cathode to said fill-detectcathode contact; an auto-on conductor disposed on said first insulatingsheet; a first dielectric layer disposed on said first insulating sheet,said first dielectric layer covering portions of said working electrodeand said counter electrode, so as to define an exposed working electrodeportion and an exposed counter electrode portion; a second dielectriclayer disposed on said first dielectric layer, said second dielectrichaving a slot, said working electrode, said counter electrode, saidfill-detect anode, and said fill-detect cathode being disposed in saidslot, said slot having a proximal end and a distal end, said proximalend of said slot being aligned with said proximal end of said firstinsulating sheet; a reagent layer disposed in said slot, said reagentlayer including glucose oxidase and a mediator; an adhesive layerdisposed on said second dielectric layer, said adhesive layer having abreak extending from said slot to a vent opening; and a secondinsulating sheet disposed on said adhesive layer, said second insulatingsheet covering said slot and at least a portion of said break, saidsecond insulating sheet having a proximal end and a distal end, saidproximal end of said second insulating sheet being aligned with saidproximal end of said slot, wherein said slot defines a sample chamber insaid test strip, said slot being dimensioned to draw said blood samplein through said proximal end of said slot by capillary action.
 2. Thetest strip of claim 1, wherein said counter electrode includes a firstsection and a second section, said working electrode being disposed onsaid first insulating sheet between said first second and said secondsection.
 3. The test strip of claim 1, wherein said at least fourelectrodes are formed by a first conductive ink printed on said firstinsulating sheet.
 4. The test strip of claim 3, wherein said firstconductive ink contains graphite.
 5. The test strip of claim 4, whereinsaid electrical contacts, said conductive traces, and said auto-onconductor are formed by a second conductive ink printed on said firstinsulating sheet.
 6. The test strip of claim 5, wherein said secondconductive ink contains silver.
 7. The test strip of claim 1, whereinsaid test strip has a thick section and a thin section, said thicksection including said proximal end, said thin section including saiddistal end, said electrical contacts and said auto-on conductor beinglocated in said thin section.
 8. The test strip of claim 1, wherein saidreagent layer covers said exposed working electrode portion.
 9. The teststrip of claim 1, wherein said second insulating sheet is transparent.10. A test strip for testing a blood sample, said test strip comprising:a sample chamber for said blood sample; at least four electrodes formeasuring at least one electrical characteristic of said blood sample insaid sample chamber, said at least four electrodes including a workingelectrode, a counter electrode, a fill-detect anode, and a fill-detectcathode; a plurality of electrical contacts electrically connected tosaid at least four electrodes; and at least one auto-on electricalcontact electrically isolated from said at least four electrodes. 11.The test strip of claim 10, further comprising: a reagent layer disposedin said sample chamber.
 12. The test strip of claim 10, wherein saidsample chamber has a first opening for receiving said blood sample and asecond opening for venting said sample chamber.
 13. The test strip ofclaim 12, wherein said sample chamber is dimensioned to draw said bloodsample in through said first opening by capillary action.
 14. The teststrip of claim 12, wherein said test strip has a proximal end and adistal end, said first opening being located at said proximal end. 15.The test strip of claim 14, wherein said proximal end is narrower thansaid distal end.
 16. The test strip of claim 14, wherein said test striphas a thick section and a thin section, said thin section including saidproximal end.
 17. The test strip of claim 16, wherein said plurality ofelectrical contacts and said at least one auto-on electrical contact arelocated in said thin section.
 18. A method of making a plurality of teststrips, said method comprising: forming a plurality of test stripstructures on a first insulating sheet, wherein each test stripstructure is formed by: (a) forming a first conductive pattern on saidfirst insulating sheet, said first conductive pattern including at leastfour electrodes, said at least four electrodes including a workingelectrode, a counter electrode, a fill-detect anode, and a fill-detectcathode; (b) forming a second conductive pattern on said firstinsulating sheet, said second conductive pattern including a pluralityof electrode contacts for said at least four electrodes, a plurality ofconductive traces electrically connecting said at least four electrodesto said plurality of electrode contacts, and an auto-on conductor; (c)applying a first dielectric layer over portions of said workingelectrode and said counter electrode, so as to define an exposed workingelectrode portion and an exposed counter electrode portion; (d) applyinga second dielectric layer to said first dielectric layer, said seconddielectric layer defining a slot, said working electrode, said counterelectrode, said fill-detect anode, and said fill-detect cathode beingdisposed in said slot; (e) forming a reagent layer in said slot, saidreagent layer including glucose oxidase and a mediator; (f) forming anadhesive layer on said second dielectric layer, said adhesive layerhaving a break extending from said slot; and (g) attaching a secondinsulating layer to said adhesive layer, such that said secondinsulating sheet covers said slot but not said electrode contacts orsaid auto-on conductor; and separating said plurality of test stripstructures into said plurality of test strips, each of said test stripshaving a proximal end and a distal end, with said slot extending to saidproximal end, said proximal end being narrower than said distal end. 19.The method of claim 18, wherein forming a first conductive pattern onsaid first insulating sheet comprises: printing a first conductive inkon said first insulating sheet, said first conductive ink containinggraphite.
 20. The method of claim 19, wherein forming a secondconductive pattern on said second insulating sheet comprises: printing asecond conductive ink on said second insulating sheet, said secondconductive ink containing silver.
 21. A method of making a plurality oftest strips, said method comprising: forming a plurality of test stripstructures on one sheet, each of said test strip structures including:(a) a sample chamber; (b) a plurality of electrodes, including a workingelectrode, a counter electrode, a fill-detect anode, and a fill-detectcathode; (c) a plurality of electrical contacts electrically connectedto said plurality of electrodes; and (d) at least one auto-on electricalcontact, electrically isolated from said plurality of electrodes; andseparating said test strip structures into said plurality of teststrips.
 22. The method of claim 21, wherein each of said test stripstructures includes a reagent layer disposed in said sample chamber. 23.The method of claim 21, wherein separating said test strip structuresinto said plurality of test strips comprises: punching said plurality oftest strip structures to form a plurality of tapered test stripstructures, each of said tapered test strip structures having a taperedsection.
 24. The method of claim 23, wherein separating said test stripstructures into said plurality of test strips further comprises:slitting said plurality of tapered test strip structures into saidplurality of test strips.
 25. A method of measuring glucose in a bloodsample, said method comprising: providing a test strip, said test striphaving a sample chamber, with a working electrode, a counter electrode,a pair of fill-detect electrodes, and a reagent layer disposed in saidsample chamber, said reagent layer including glucose oxidase and amediator, said test strip including an auto-on conductor; inserting saidtest strip into a meter, said meter being in a sleep mode; said meterdetecting an auto-on current through said auto-on conductor andresponsively entering an active mode; said meter validating said workingand counter electrodes by applying a first validation voltage betweensaid working and counter electrodes; said meter validating saidfill-detect electrodes by applying a second validation voltage betweensaid fill-detect electrodes, while said first validation voltage isapplied between said working and counter electrodes; applying said bloodsample to said sample chamber; said meter detecting said blood sample ata first location in said sample chamber by applying a drop-detectvoltage between said working and counter electrodes and measuring adrop-detect current flowing between said working and counter electrodes;said meter detecting said blood sample at a second location in saidsample chamber by applying a fill-detect voltage between saidfill-detect electrodes and measuring a fill-detect current flowingbetween said fill-detect electrodes; after waiting an incubation timeperiod, said meter applying an assay voltage between said working andcounter electrodes and making at least one measurement of the resultingcurrent through said working electrode; and said meter determining ameasured glucose level from said at least one current measurement. 26.The method of claim 25, further comprising: said auto-on currentdeveloping an auto-on voltage drop across said auto-on conductor; andsaid meter measuring said auto-on voltage drop.
 27. The method of claim25, further comprising: said meter measuring any leakage current throughsaid working electrode, while applying said first validation voltagebetween said working and counter electrodes; and if said leakage currentexceeds a first predetermined level, said meter indicating an errorcondition.
 28. The method of claim 25, further comprising: said metermeasuring any leakage current through one of said fill-detectelectrodes, while applying said first validation voltage between saidworking and counter electrodes and said second validation voltagebetween said fill-detect electrodes; and if said leakage current exceedsa second predetermined level, said meter indicating an error condition.29. The method of claim 25, further comprising: if said drop-detectcurrent does not reach a drop-detect threshold value within apredetermined time period, said meter indicating an error condition. 30.The method of claim 25, further comprising: if said drop-detect currentreaches a drop-detect threshold value within a predetermined timeperiod, said meter: a) switching said working and counter electrodes toa high impedance state relative to said fill-detect electrodes; b)starting a fill time period; and c) starting said incubation timeperiod.
 31. The method of claim 30, further comprising: if saidfill-detect current does not reach a fill-detect threshold value withinsaid fill time period, said meter indicating an error condition.
 32. Themethod of claim 30, further comprising: if said fill-detect currentreaches a fill-detect threshold value within said fill time period, saidmeter providing a user-discernible indication.
 33. A method of using atest strip to test a blood sample, said test strip including a samplechamber, a working electrode, a counter electrode, a pair of fill-detectelectrodes, and an auto-on conductor, said method comprising: insertingsaid test strip into a meter, said meter being in a sleep mode; saidmeter detecting an auto-on current through said auto-on conductor andresponsively entering an active mode; applying said blood sample to saidsample chamber; said meter detecting said blood sample in said samplechamber by applying a fill-detect voltage between said fill-detectelectrodes and measuring a fill-detect current flowing between saidfill-detect electrodes; said meter applying an assay voltage betweensaid working and counter electrodes and making at least one measurementof the resulting current; and said meter determining a test result fromsaid at least one current measurement.
 34. The method of claim 33,further comprising: said auto-on current developing an auto-on voltagedrop across said auto-on conductor; and said meter measuring saidauto-on voltage drop.
 35. The method of claim 33, further comprising: ifsaid fill-detect current reaches a fill-detect threshold value within apredetermined time period, said meter providing a user-discernibleindication.
 36. The method of claim 33, further comprising: said meterdetecting said blood sample in said sample chamber by applying adrop-detect voltage between said working and counter electrodes andmeasuring a drop-detect current flowing between said working and counterelectrodes.
 37. The method of claim 36, further comprising: if saiddrop-detect current reaches a drop-detect threshold value within apredetermined time period, said meter starting an incubation timeperiod.
 38. The method of claim 37, wherein said meter applies saidassay voltage after said incubation time period.
 39. A method of stripidentification, said method comprising: inserting a strip into a meter,said strip including an auto-on conductor, said meter being in a sleepmode; said meter detecting said strip, by detecting a current flowthrough said auto-on conductor, and responsively entering an activemode; said meter measuring a voltage drop across said auto-on conductor;said meter identifying said strip as either a test strip or a checkstrip based on said voltage drop; if said strip is a test strip, saidmeter performing a test strip sequence; and if said strip is a checkstrip, said meter performing a check strip sequence.
 40. The method ofclaim 39, wherein said meter identifies said strip as a test strip ifsaid voltage drop is below a predetermined value.
 41. The method ofclaim 40 wherein said meter identifies said strip as a quality controlstrip if said voltage drop is above said predetermined value.
 42. Aremovable data storage device for a meter, said meter measuring usingtest strips to measure glucose levels in blood samples, said removabledata storage device comprising: a carrier having a proximal end and adistal end, said carrier being keyed for inserting said distal end intosaid meter in a preferred orientation; a circuit board mounted to saidcarrier, said circuit board including a plurality of electrical contactsfor electrically connecting to said meter, said plurality of electricalcontacts including a ground contact and a voltage supply contact, saidground contact extending closer to said distal end than said voltagesupply contact; and a memory mounted to said circuit board andelectrically connected to said plurality of electrical contacts, saidmemory storing data for use by said meter, said data including at leastone calibration parameter for use with at least one test strip, wherebywhen said removable data storage device is inserted into said meter insaid preferred orientation, said ground contact becomes electricallyconnected to said meter before said voltage supply contact.
 43. Theremovable data storage device of claim 42, wherein said at least onecalibration parameter corrects for temperature.
 44. The removable datastorage device of claim 42, wherein said data identifies a brand of saidat least one test strip.
 45. The removable data storage device of claim42, wherein said data identifies a model of said meter.
 46. Theremovable data storage device of claim 42, wherein said data identifiesan expiration date of said at least one test strip.
 47. The removabledata storage device of claim 42, wherein said data specifies at leastone time period duration to be used by said meter.
 48. The removabledata storage device of claim 42, wherein said data specifies at leastone voltage to be used by said meter.
 49. The removable data storagedevice of claim 42, wherein said data specifies a number of currentmeasurements to be taken by said meter.
 50. The removable data storagedevice of claim 49, wherein said data specifies an averaging method ofsaid current measurements.
 51. A meter for use in combination with atest strip for measuring a glucose level in a blood sample applied to asample chamber in said test strip, said test strip having at least fourelectrodes disposed in said sample chamber, said at least fourelectrodes including a working electrode, a counter electrode, and apair of fill-detect electrodes, said test strip having a thin sectionand a thick section, said thin section including a plurality of teststrip contacts for said at least four electrodes and an auto-onconductor, said meter comprising: a first connector for receiving saidtest strip, said first connector including meter contacts forelectrically connecting to said test strip contacts and said auto-onconductor, said first connector being sized to receive said thin sectionbut not said thick section of said test strip; a second connector forreceiving a removable data storage device, said removable data storagedevice storing data for use by said meter; a processor; a memory; adisplay; a plurality of machine language instructions stored in saidmemory and executable by said processor for: a) saving said data fromsaid removable data storage device into said memory; b) performing atest strip sequence when said test strip is inserted in said firstconnector to obtain at least one current measurement related to saidglucose level; c) determining a glucose level in said blood sample fromsaid at least one current measurement and said data stored in saidmemory; and d) displaying said glucose level on said display; a firstelectrode circuit for applying at least a first voltage, selected bysaid processor, between said working and counter electrodes when saidtest strip is inserted in said first connector, said first electrodecircuit including a first digital-to-analog converter; a secondelectrode circuit for applying at least a second voltage, selected bysaid processor, between said fill-detect electrodes when said test stripis inserted in said first connector, said second electrode circuitincluding a second digital-to-analog converter; an auto-on circuit fordeveloping an auto-on current through said auto-on conductor when saidtest strip is inserted in said first connector and for bringing saidmeter from a sleep mode to an active mode in response to said auto-oncurrent; and at least one analog-to-digital converter for measuringcurrents flowing between said working and counter electrodes and flowingbetween said fill-detect electrodes and for measuring an auto-on voltagedrop across said auto-on conductor resulting from said auto-on current.52. The meter of claim 51, wherein said test strip sequence comprises:validating said working and counter electrodes by applying a firstvalidation voltage between said working and counter electrodes;validating said fill-detect electrodes by applying a second validationvoltage between said fill-detect electrodes, while said first validationvoltage is applied between said working and counter electrodes;detecting said blood sample at a first location in said sample chamberby applying a drop-detect voltage between said working and counterelectrodes and measuring a drop-detect current flowing between saidworking and counter electrodes; detecting said blood sample at a secondlocation in said sample chamber by applying a fill-detect voltagebetween said fill-detect electrodes and measuring a fill-detect currentflowing between said fill-detect electrodes; and after waiting anincubation time period, applying an assay voltage between said workingand counter electrodes and making at least one measurement of theresulting current flowing between said working and counter electrodes.53. A meter for use in combination with a test strip, said test stripincluding a working electrode, a counter electrode, a pair offill-detect electrodes, and an auto-on conductor, said meter comprising:a strip connector for receiving said test strip; a processor; a memory;a plurality of machine instructions stored in said memory and executableby said processor for performing a test strip sequence; a dataacquisition system, controlled by said processor, for applying at leasta first voltage between said working and counter electrodes andmeasuring any resulting current flowing between said working and counterelectrodes, for applying at least a second voltage between saidfill-detect electrodes and measuring any resulting current flowingbetween said fill-detect electrodes, and for measuring a voltage dropacross auto-on conductor, when said test strip is inserted in said stripconnector, said data acquisition system including at least onedigital-to-analog converter and at least one analog-to-digitalconverter.
 54. The meter of claim 53, wherein said data acquisitionsystem includes a wake-up circuit, said wake-up circuit detecting saidauto-on conductor when said test strip is inserted in said stripconnector and responsively bringing said data acquisition system from asleep mode into an active mode.
 55. The meter of claim 53, wherein saidtest strip sequences comprises: applying an assay voltage between saidworking and counter electrodes and making at least one measurement ofthe resulting current flowing between said working and counterelectrodes.
 56. The meter of claim 55, wherein said test strip sequencefurther comprises: detecting said blood sample in said sample chamber byapplying a fill-detect voltage between said fill-detect electrodes andmeasuring a fill-detect current flowing between said fill-detectelectrodes.
 57. The meter of claim 56, wherein said test strip sequencefurther comprises: detecting said blood sample at a first location insaid sample chamber by applying a drop-detect voltage between saidworking and counter electrodes and measuring a drop-detect currentflowing between said working and counter electrodes.